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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03540433




Registration number
NCT03540433
Ethics application status
Date submitted
17/05/2018
Date registered
17/05/2018
Date last updated
13/06/2018

Titles & IDs
Public title
International Observational Study on Perioperative Cognitive Trajectories (POCD Census International/PCI)
Scientific title
Evaluation of POCD-Census Prospective, International Observation Study
Secondary ID [1] 0 0
PCI
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Cognitive Deficit (POCD) 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Learning disabilities
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Study group - Surgical patients aged =70 years

Control group - Healthy subjects, aged =70 years, American Society of Anesthesiologists (ASA) I+II+III, no surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of postoperative cognitive dysfunction (POCD) - Neuropsychological testing
Timepoint [1] 0 0
Up to 1 year
Secondary outcome [1] 0 0
Incidence of postoperative cognitive dysfunction (POCD) - Neuropsychological testing
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Mild Neurocognitive Disorder - Definition according to DSM-V as proposed in Evered L et al. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery. Br J Anaesth, Anesthesiology, Can J Anesth, Anesth Analg, J Alz Dis, acta scandinavica anaesthesiologica (Joint Publication) 2017; Accepted, In Press. We will use an I-pad based neuropsychological test battery (CANTAB connect), and cognitive screening instruments (MOCA, Mini-Cog™ and Animal naming test on verbal fluency from ACE-R) for assessment of cognitive function, MMQ and IQ-code for self- or by proxy reported cognitive concern and ADL/IADL for assessment of functional status. Mild/major Neurocognitive Disorder wis measured at baseline (pre-existing NCD) 3 months and 1 year (with specifier 'POCD'), 2- and 5 years after surgery
Timepoint [2] 0 0
Up to five years
Secondary outcome [3] 0 0
Major Neurocognitive Disorder - Definition according to DSM-V as proposed in Evered L et al. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery. Br J Anaesth, Anesthesiology, Can J Anesth, Anesth Analg, J Alz Dis, acta scandinavica anaesthesiologica (Joint Publication) 2017; Accepted, In Press. We will use an I-pad based neuropsychological test battery (CANTAB connect), and cognitive screening instruments (MOCA, Mini-Cog™ and Animal naming test on verbal fluency from ACE-R) for assessment of cognitive function, MMQ and IQ-code for self- or by proxy reported cognitive concern and ADL/IADL for assessment of functional status. Mild/major Neurocognitive Disorder wis measured at baseline (pre-existing NCD) 3 months and 1 year (with specifier 'POCD'), 2- and 5 years after surgery
Timepoint [3] 0 0
Up to five years
Secondary outcome [4] 0 0
Dementia - Diagnosis of dementia based on clinical criteria (DSM-V and NIA-AA) and supported - if patients consents on lumbar puncture and blood sampling - biomarkers from blood and spinal fluid (blood (beta Amyloid 1-40, beta-Amyloid 1-42, beta-Amyloid Ratio (42/40*10), phospho-TAU, Protein 14-3-3, PRPSc, TAU (Gesamt-Tau), Apolipoprotein E).
Timepoint [4] 0 0
Up to five years
Secondary outcome [5] 0 0
Comorbidities - Comorbidities will be quantified by use of Charlson Comorbidity index
Timepoint [5] 0 0
Up to five years
Secondary outcome [6] 0 0
Surgical risk - Surgical risk will be described by type and length of surgery and perioperative cardiac risk estimation as described in Anästh Intensivmed 2017; 58:349-364.
Timepoint [6] 0 0
Participants will be followed up during surgery, an estimated duration of 1 hour
Secondary outcome [7] 0 0
Intraoperative depth of anaesthesia - Intraoperative depth of sedation will be monitored with changes in the pattern and power spectrum of EEG-raw data measured with the Masimo SedLine® brain function monitoring for Root®, Narcotrend®, BIS™ and additionally quantified by indices [e.g. PSI or BIS-index] and burst suppression ratio.
Timepoint [7] 0 0
Participants will be followed up during surgery, an estimated duration of 1 hour
Secondary outcome [8] 0 0
Depth of sedation on the Intensive Care Unit - Sedation is measured by Richmond Agitation Sedation Scale.
Timepoint [8] 0 0
Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Secondary outcome [9] 0 0
Sedation on the peripheral ward - Sedation is measured by Richmond Agitation Sedation Scale.
Timepoint [9] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [10] 0 0
Agitation on the peripheral ward - Agitation describes a clinical state in which the patient may be impulsive and attempt to get out of bed, to wander, and to fall (which may lead to further injury or death) and attempt to remove IV lines, tubes, or catheters.
Timepoint [10] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [11] 0 0
Incidence of postoperative delirium - Postoperative delirium rate, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V), CAM/CAM-ICU, Nu-DESC and Chart Review.
Timepoint [11] 0 0
Up to 5 days
Secondary outcome [12] 0 0
Pain scale for patients able of pain self-assessment - Pain during hospital stay will be measured with the Numeric Rating Scale (NRS-V).
Timepoint [12] 0 0
Up to hospital discharge, an expected average of 5 days
Secondary outcome [13] 0 0
Pain scales for patients unable of pain self-assessment - For patients unable of pain self-assessment (e.g. ventilated patients, patients in delirious state or patients with stroke affecting language skills) observer-rated pain scales will be applied: Behavioural Pain Scale (BPS for ventilated) and BPS-NI (for non-ventilated) patients, Critical-Care Pain Observation Tool (CPOT) during hospital stay.
Timepoint [13] 0 0
Up to hospital discharge, an expected average of 5 days
Secondary outcome [14] 0 0
Intensive care unit length of stay - Intensive care unit length of stay describes every day spent in an ICU bed.
Timepoint [14] 0 0
Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Secondary outcome [15] 0 0
Hospital length of stay - Hospital length of stay describes every day spent in an hospital.
Timepoint [15] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [16] 0 0
Perioperative Anxiety - Perioperative anxiety will be measured with APAIS preoperatively and the Faces Anxiety Scale (FAS) and during hospital stay.
Timepoint [16] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [17] 0 0
Generalized anxiety - Anxiety will be measured with the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Timepoint [17] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [18] 0 0
Depression - Depression is measured by PHQ-9. Scores represent:0-5 = mild, 6-10 = moderate, 11-15 = moderately severe, 16-20 = severe depression
Timepoint [18] 0 0
Up to 5 years
Secondary outcome [19] 0 0
Quality of sleep - Quality of sleep is measured by the Insomnia Severity Index.
Timepoint [19] 0 0
Up to 5 years
Secondary outcome [20] 0 0
Routine laboratory - No additional blood samples will be taken in the pilotstudy
Timepoint [20] 0 0
Up to hospital discharge, an expected average of 7 days
Secondary outcome [21] 0 0
Organ dysfunctions - Organ dysfunctions are evaluated according to the Clavien-Dindo classification of surgical complications
Timepoint [21] 0 0
Up to hospital discharge, an expected average of 7 days
Secondary outcome [22] 0 0
Medication - Prescribed regular drug intake from baseline at all follow ups including perioperative application of drugs, infusions and transfusions will be evaluated.
Timepoint [22] 0 0
Up to 5 years
Secondary outcome [23] 0 0
Quality of life - Quality of life will be measured with the EQ-5D
Timepoint [23] 0 0
Up to 5 years
Secondary outcome [24] 0 0
Level of dependency - Level of dependency will be measured with with ADL/IADL, single items concerning patients' living situation and the BSSS-17 (Berlin Social Support Scales).
Timepoint [24] 0 0
Up to 5 years
Secondary outcome [25] 0 0
Re-admission - Hospital readmission is an episode when a patient who had been discharged from a hospital is admitted again within a specified time interval.
Timepoint [25] 0 0
Up to 5 years
Secondary outcome [26] 0 0
Revison surgery - Surgery performed to replace or compensate for a failed implant or to correct undesirable sequelae of previous surgery.
Timepoint [26] 0 0
Up to 5 years
Secondary outcome [27] 0 0
Outpatient treatment - Treatment outside of the hospital in an associated facility for diagnosis or treatment.
Timepoint [27] 0 0
Up to 5 years
Secondary outcome [28] 0 0
Mortality - The number of deaths in a given period.
Timepoint [28] 0 0
Up to 5 years

Eligibility
Key inclusion criteria
- Surgical patients at Campus Virchow- Klinikum and Campus Charité Mitte

- Aged = 70 years

- Informed consent
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Manifest dementia

- Lack of willingness to store and disseminate pseudonymised disease data as part of the
clinical trial

- Lack of readiness to participate in the follow-up examinations and contact to make an
appointment

- Placement in an institute under judicial or official orders (according to German drug
Law §40 (1) 4)

- Persons without a permanent residence or other circumstances that call into question
the availability by telephone or post for postoperative examination

- Employees of the respective study centers

- illiteracy

- Patients with a neuropsychiatric condition that limits the performance of
neurocognitive testing

- Patients with hearing and / or vision problems that limit the performance of
neuro-cognitive testing

- Simultaneous participation in a prospective clinical intervention study

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Melbourn
Recruitment hospital [1] 0 0
Department of Anaesthesia, St. Vincents`s Hospital - Fitzroy
Recruitment postcode(s) [1] 0 0
VIC 3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Berlin
Country [2] 0 0
Spain
State/province [2] 0 0
Valladolid
Country [3] 0 0
Sweden
State/province [3] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Other
Name
Charite University, Berlin, Germany
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this international, multi-centre observational study is to describe
perioperative cognitive changes (pre-existing neurocognitive disorder [NCD], postoperative
delirium [POD] and Postoperative Cognitive Dysfunction [POCD]) up to five years after
elective surgery in a mixed cohort. Measurements and definitions of cognitive outcomes will
be based on current consensus and used for further harmonization in future clinical studies
on perioperative cognitive trajectories. This is a feasibility approach to identify an
effective screening procedure and estimate loss to follow up rates for the planning of future
intervention studies. Data from this trial may also serve to facilitate and implement time
effective cognitive screening and risk stratification concerning postoperative cognitive
decline in the anaesthesiological preoperative assessment.
Trial website
https://clinicaltrials.gov/show/NCT03540433
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Claudia Spies, MD, Prof.
Address 0 0
Charite University, Berlin, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Claudia Spies, MD, Prof.
Address 0 0
Country 0 0
Phone 0 0
+49 30 450 55 10 01
Fax 0 0
Email 0 0
claudia.spies@charite.de
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable